BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAS MODULE II

    MDR report key: 3091529 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00326
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    August 22, 2012
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    BZK
    PMA / PMN Number
    062754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EVALUATED THE UNIT. CORRECTIONS INCLUDED REPLACEMENT OF THE TUBING BETWEEN THE O2 FILTER AND O2 SENSOR. THE UNIT WAS TESTED TO FACTORY'S SPECS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LOSS OF GAS READINGS ON THE GAS MODULE II. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186917 GAS MODULE II GAS MODULE II BZK MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1